title: Recommendations for collection and handling of specimens from group breast cancer clinical trials.
abstract: Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exists is minimized and specimen condition and quality are enhanced, thereby maximizing results from specimen-based diagnostic testing and research. Three working groups were formed from the Cooperative Group Banking Committee, BIG groups, and North American breast cancer cooperative groups to identify standards for collection and handling of (1) formalin-fixed, paraffin-embedded (FFPE) tissue; (2) blood and its components; and (3) fresh/frozen tissue from breast cancer trials. The working groups collected standard operating procedures from multiple group specimen banks, administered a survey on banking practices to those banks, and engaged in a series of discussions from 2005 to 2007. Their contributions were synthesized into this document, which focuses primarily on collection and handling of specimens to the point of shipment to the central bank, although also offers some guidance to central banks. Major recommendations include submission of an FFPE block, whole blood, and serial serum or plasma from breast cancer clinical trials, and use of one fixative and buffer type (10% neutral phosphate-buffered formalin, pH 7) for FFPE tissue across trials. Recommendations for proper handling and shipping were developed for blood, serum, plasma, FFPE, and fresh/frozen tissue.
authors.affiliation: Emory University School of Medicine, Atlanta, GA 30322, USA. leyland@emory.edu
authors.forename: Brian R
authors.initials: BR
authors.lastname: Leyland-Jones
authors.forename: Christine B
authors.initials: CB
authors.lastname: Ambrosone
authors.forename: John
authors.initials: J
authors.lastname: Bartlett
authors.forename: Matthew J C
authors.initials: MJ
authors.lastname: Ellis
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Enos
authors.forename: Adekunle
authors.initials: A
authors.lastname: Raji
authors.forename: Michael R
authors.initials: MR
authors.lastname: Pins
authors.forename: Jo Anne
authors.initials: JA
authors.lastname: Zujewski
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Hewitt
authors.forename: John F
authors.initials: JF
authors.lastname: Forbes
authors.forename: Mark
authors.initials: M
authors.lastname: Abramovitz
authors.forename: Sofia
authors.initials: S
authors.lastname: Braga
authors.forename: Fatima
authors.initials: F
authors.lastname: Cardoso
authors.forename: Nadia
authors.initials: N
authors.lastname: Harbeck
authors.forename: Carsten
authors.initials: C
authors.lastname: Denkert
authors.forename: Scott D
authors.initials: SD
authors.lastname: Jewell
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis / Q000473:pathology* / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D004992:Ethics, Medical; D005557:Formaldehyde / Q000494:pharmacology; D017408:Guidelines as Topic; D006801:Humans; D054547:National Cancer Institute (U.S.); D016612:Paraffin Embedding; D013048:Specimen Handling / Q000379:methods* / Q000592:standards*; D014015:Tissue Banks; D014481:United States
chemical_list: D005557:Formaldehyde